Quality Vs Validation – Protocol Acceptance Criteria

So the Validation Department generate the protocol and the Quality Department are involved in reviewing the protocol. Having worked on various different projects it has become quite apparent that the quality review on any protocol is a very important review as it irons out all of the documentation mistakes that occur when the document is being generated.

Quality Vs Validation - Good Vs Evil

On the other hand I often wonder if quality takes this review too far, and if they do why?

Quality Review

For example if you have a quality person reviewing an IQ or OQ protocol on a computer application, is it acceptable for them to review it having little knowledge of the application.

Does this lead to the quality person reviewing the protocol with an overly cautious approach to the point where the validation engineer is ready to pull their hair out in frustration.

A Simple Scenario

Lets take a very simple scenario. A test protocol usually has the following fields:

Test Procedure

Acceptance criteria

Meets Acceptance Criteria Yes/No

Performed by /Date

The column to take note of in this scenario is the Acceptance Criteria and the Performed by/Date field.

Lets discuss the acceptance criteria field first, this field usually contains the criteria that must be met in order to pass a test section. If the test is carried out and the acceptance criteria are not met then this usually results in a deviation or an event being raised.

I don’t think anyone has an issue with this scenario, but in terms of acceptance criteria what is acceptable?

Is this acceptable from a quality perspective though, I mean when you sign the performed by section do you mean that the test has been completed or do you mean that the deviation message was displayed and the test was completed.

Screenshots

If the quality department are not happy with the latter then they will require a screenshot as evidence that the deviation message was displayed.

Do you see what I am getting at here; does this mean that screenshots are required for all acceptance criteria?

If so then your protocol will contain numerous attachments and a long review time.

Before your protocol is approved you really need to work closely with the quality department in order to understand what is acceptable from an acceptance criteria view point.

If you would like further assistance with protocol generation please feel free to contact Premier Validation

Documentation corrections do not equal spelling mistakes. There is more to a quality review that just spell check. On the surface it seems so much easier to have to review a document than having to create it in the first place. Having to write a protocol for anyone to understand decreases the efficiencies of the risk based approach or quality by design. IMHO it is incumbent of the quality approver to educate him/herself of the application in question before/while approving. Approval should be an iterative process to deliver the best qualification document.

Documentation corrections do not equal spelling mistakes. There is more to a quality review that just spell check. On the surface it seems so much easier to have to review a document than having to create it in the first place. Having to write a protocol for anyone to understand decreases the efficiencies of the risk based approach or quality by design. IMHO it is incumbent of the quality approver to educate him/herself of the application in question before/while approving. Approval should be an iterative process to deliver the best qualification document.

Quality involvement on Computer validation is essential to success, but also to concentrate on relevant testing and documentation. We can take tons of screenshots as evidence of standard functionalities (hardly tested by the supplier) and miss the opportunity to test critical or risky configuration. Then we have a very nice but useless documentation. In other words, validation effort should be focussed on demonstrating that system (or system configurations) meet the user processes without compromising electronic records. Documentation is a part, not the goal of validation, and quality people not always has this view. In my opinion, testing must be done by a well-trained or experienced user who write “pass/not pass” and sign the execution. A second user (witness or not) review the results and take part on resolution of fails/non conformities. We use to involve QA as final test reviewer (and protocol/report approvers).

Quality involvement on Computer validation is essential to success, but also to concentrate on relevant testing and documentation. We can take tons of screenshots as evidence of standard functionalities (hardly tested by the supplier) and miss the opportunity to test critical or risky configuration. Then we have a very nice but useless documentation. In other words, validation effort should be focussed on demonstrating that system (or system configurations) meet the user processes without compromising electronic records. Documentation is a part, not the goal of validation, and quality people not always has this view. In my opinion, testing must be done by a well-trained or experienced user who write “pass/not pass” and sign the execution. A second user (witness or not) review the results and take part on resolution of fails/non conformities. We use to involve QA as final test reviewer (and protocol/report approvers).

1) prior to writing a protocol, I recommend that a team be established including the writer, the system owner, and the quality reviewer. This allows the team members to learn their strengths, weaknesses, and personality traits (if the quality reviewer is weak in computer validation the others can diplomatically provide suggestions, learn that the quality reviewer is not open to suggestions, or learn what the quality reviewer expects). Having written over a hundred protocols, I highly recommend this.

2) prior to writing a protocol, I recommend that the writer generate an outline of what will be tested and identify the template to be used (to achieve team consensus). For example, I recommend that you include columns for “Expected Results” and “Actual Results” so that the reviewer can determine if actual results met expected results.

3) getting to know the team members before writing the protocol improves the likelihood of it being right-first-time (minimizing protocol approval time and protocol review time after execution).

4) it is important that a protocol be written such that execution and review is not open to interpretation (the team, including the executor, knows what is expected as does the reviewer). As an example, state when a screenshot is required (attach printout demonstrating that ….). Screenshots are required to demonstrate tasks have been performed successfully. As a rule of thumb, one or two, per test case.

1) prior to writing a protocol, I recommend that a team be established including the writer, the system owner, and the quality reviewer. This allows the team members to learn their strengths, weaknesses, and personality traits (if the quality reviewer is weak in computer validation the others can diplomatically provide suggestions, learn that the quality reviewer is not open to suggestions, or learn what the quality reviewer expects). Having written over a hundred protocols, I highly recommend this.

2) prior to writing a protocol, I recommend that the writer generate an outline of what will be tested and identify the template to be used (to achieve team consensus). For example, I recommend that you include columns for “Expected Results” and “Actual Results” so that the reviewer can determine if actual results met expected results.

3) getting to know the team members before writing the protocol improves the likelihood of it being right-first-time (minimizing protocol approval time and protocol review time after execution).

4) it is important that a protocol be written such that execution and review is not open to interpretation (the team, including the executor, knows what is expected as does the reviewer). As an example, state when a screenshot is required (attach printout demonstrating that ….). Screenshots are required to demonstrate tasks have been performed successfully. As a rule of thumb, one or two, per test case.

Something to keep in mind is that there are several common rationales or approaches to validation. These can typically vary by company, by division within a company, or even by the project that you are representing. Understanding the validation approach for your particular project is critical if you expect to be successful when it comes time for a quality review. Deliverable types that were acceptable on your last project may no longer apply, even for the same type of system.

For example, if your project follows a risk-based approach there will be specific criteria that quality uses as a measuring stick. You may have a full suite of system lifecycle documentation, such as User Requirements, Functional Specifications, and/or a Design Specification of some sort. Depending on how the risk-based approach is structured, quality may expect your protocol to include verifications of specific elements from within these lifecycle documents. Your role in a project may be focused on protocol development, however, it’s critical that you understand validation rationales that may already be planned for your project. This is in alignment with comments by Jeff that you should familiarize yourself with quality’s expectations.

To summarize, while it’s crucial that protocols and test cases be structured in a manner that eliminates ambiguity, understanding the rationales for testing and the appropriate deliverables that feed into the qualification effort are foundational when it comes time for a quality review.

As a caveat, there are clearly organizations who don’t require indepth planning or advanced rationales when planning a validation effort. Whereas understanding a risk-based approach to protocol writing is critical if you want to be successful in a risk-based environment, communication of expectations is equally critical in a less rigorous business environment. In either case, the key to successful protocol development is understanding the basis that quality will be using when it’s time to review your work.

Something to keep in mind is that there are several common rationales or approaches to validation. These can typically vary by company, by division within a company, or even by the project that you are representing. Understanding the validation approach for your particular project is critical if you expect to be successful when it comes time for a quality review. Deliverable types that were acceptable on your last project may no longer apply, even for the same type of system.

For example, if your project follows a risk-based approach there will be specific criteria that quality uses as a measuring stick. You may have a full suite of system lifecycle documentation, such as User Requirements, Functional Specifications, and/or a Design Specification of some sort. Depending on how the risk-based approach is structured, quality may expect your protocol to include verifications of specific elements from within these lifecycle documents. Your role in a project may be focused on protocol development, however, it’s critical that you understand validation rationales that may already be planned for your project. This is in alignment with comments by Jeff that you should familiarize yourself with quality’s expectations.

To summarize, while it’s crucial that protocols and test cases be structured in a manner that eliminates ambiguity, understanding the rationales for testing and the appropriate deliverables that feed into the qualification effort are foundational when it comes time for a quality review.

As a caveat, there are clearly organizations who don’t require indepth planning or advanced rationales when planning a validation effort. Whereas understanding a risk-based approach to protocol writing is critical if you want to be successful in a risk-based environment, communication of expectations is equally critical in a less rigorous business environment. In either case, the key to successful protocol development is understanding the basis that quality will be using when it’s time to review your work.

Nice Post! As I work for a large company with many branches, I have had to work closely with the various Responsible Head of Quality. My experience has shown that one has to understand the Quality “Person” to be able to understand their individual needs. Some are more prone to checking the basic fundimentals such as the font,size, shades of grey, etc of the documentation while others are extremely stroppy with spelling and grammer and yet have no idea of the various tests that are to be performed. Others ignore this and show a keen interest in the why, when, and what’s of the script that one is bombarded with so many questions that one starts to question your own protocol writing skills!! lol.

As every person has a different outlook/way of doing something such as protocols, as a Protocol writer/executioner (grin..) at least ones life will never be boring.

Nice Post! As I work for a large company with many branches, I have had to work closely with the various Responsible Head of Quality. My experience has shown that one has to understand the Quality “Person” to be able to understand their individual needs. Some are more prone to checking the basic fundimentals such as the font,size, shades of grey, etc of the documentation while others are extremely stroppy with spelling and grammer and yet have no idea of the various tests that are to be performed. Others ignore this and show a keen interest in the why, when, and what’s of the script that one is bombarded with so many questions that one starts to question your own protocol writing skills!! lol.

As every person has a different outlook/way of doing something such as protocols, as a Protocol writer/executioner (grin..) at least ones life will never be boring.

Interesting that there seems to be such animosity between validation teams and quality teams. I work for a very small company and the quality and validation duties overlap as far as responsible personnel.
I have had to do much educating here on what the purpose of validations are in order to be able to work well with all departments. And truthfully, the manufacturing departments are the most resistant to performing validations.
Maybe this is a strange question, but don’t validation teams want their documents to meet all of the quality standards too? If a question the quality reviewer brings up cannot be answered easily, then maybe the quality reviewer has a point…?
In our company, the quality department handles most of the external audits and must assist in defending documents to customers, ISO auditors, and government auditors. As both a quality and validation position, I definetly don’t want to be caught in a position with an auditor of any kind where I cannot defend or explain any part of a validation document…

Interesting that there seems to be such animosity between validation teams and quality teams. I work for a very small company and the quality and validation duties overlap as far as responsible personnel.
I have had to do much educating here on what the purpose of validations are in order to be able to work well with all departments. And truthfully, the manufacturing departments are the most resistant to performing validations.
Maybe this is a strange question, but don’t validation teams want their documents to meet all of the quality standards too? If a question the quality reviewer brings up cannot be answered easily, then maybe the quality reviewer has a point…?
In our company, the quality department handles most of the external audits and must assist in defending documents to customers, ISO auditors, and government auditors. As both a quality and validation position, I definetly don’t want to be caught in a position with an auditor of any kind where I cannot defend or explain any part of a validation document…